On September 8, 2026 Adlai Nortye Group Ltd. (NASDAQ: ANL) ("Adlai Nortye" or the "Company"), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, reported that the first patient has been dosed with AN4035 in Australia, initiating the global Phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors. The Company also received a "Study-May-Proceed" letter from the U.S. Food and Drug Administration (FDA) on its investigational new drug (IND) application, clearing the path to expand the trial into the United States.

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"AN4035 is the first proof-of-concept candidate from our RAS Inhibitor Conjugated Antibody (RASiCA) platform, specifically engineered to address two pressing challenges in oncology. First, the ADC field urgently needs novel payload classes to overcome cross-resistance, as existing options remain largely confined to just topoisomerase I and microtubule inhibitors. Second, systemic pan-RAS(ON) inhibitors have been hampered by on-target, off-tumor toxicities, particularly in the skin and gastrointestinal tract. By conjugating our potent pan-RAS(ON) payload to a CEACAM5-targeting antibody, AN4035 is designed for tumor-selective delivery while sparing normal tissues," said Dr. Archie Tse, President, Head of Research & Development. "Following regulatory clearance to begin the trial in Australia last month, we have dosed the first patient and secured a "Study-May-Proceed" letter from the U.S. FDA. We look forward to advancing this asset globally and remain on track to report full Phase Ia data in the second half of 2027."

This global phase I trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 as monotherapy and in combination with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors. CEACAM5 is highly overexpressed in colorectal, pancreatic, and lung cancers – tumor types that frequently harbor RAS mutations. The Company is also filing an IND application for AN4035 with the China National Medical Products Administration (NMPA).

About AN4035

AN4035 is a first-in-class ADC targeting CEACAM5 and armed with a highly potent pan-RAS(ON) inhibitor payload. In preclinical studies, the ADC demonstrates favorable thermal and plasma stability with desirable pharmacokinetic properties. Strong intracellular payload retention drives nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cancer cell lines, coupled with a potent bystander-killing effect. In vivo, AN4035 has shown robust anti-tumor activity with deep tumor regression in CEACAM5-positive CDX and PDX models. Compared with the payload alone, the ADC exhibits enhanced target-mediated tumor retention and significantly improved tumor selectivity over normal tissues, resulting in an overall favorable therapeutic index. Adlai Nortye is evaluating AN4035 in a global phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors.

(Press release, Adlai Nortye Biopharma, SEP 8, 2026, View Source [SID1234670661])

On September 8, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported new clinical data for KRASG12C inhibitor BBO-8520 and the strategic prioritization of (i) BBO-8520 in combination with checkpoint inhibitor in 2L+ KRASG12C inhibitor-experienced non-small cell lung cancer (NSCLC) patients and (ii) BBO-11818 and BBO-10203 combinations in KRAS-mutant cancers.

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"Across our portfolio, all three programs have now generated encouraging clinical data supporting further development, enabling us to focus our capital on the opportunities with the highest probability of success, clearest development paths, and greatest potential patient benefit," said Pedro J. Beltran, Ph.D., Chief Executive Officer of BBOT. "With a strong balance sheet and multiple data catalysts through mid-2027, we believe BBOT is well positioned to advance differentiated therapies for patients with KRAS-driven cancers."

BBO-8520 (Direct KRASG12C ON/OFF Inhibitor) Key Findings:

BBO-8520 is an oral, direct KRASG12C(ON/OFF) inhibitor. By directly inhibiting both the ON and OFF states of KRASG12C, BBO-8520 is designed to achieve potent pathway inhibition at lower free-drug exposures and enable combination with checkpoint inhibition. In the ongoing ONKORAS-101 (NCT06343402) Phase 1 study (data cutoff: June 1, 2026):

BBO-8520 in combination with pembrolizumab in NSCLC KRASG12C inhibitor-experienced patients showed:

Objective response rate (ORR): 75% at the 500 mg once-daily (QD) dose level and 53% across all dose levels (N=17).
Generally tolerable and manageable safety profile. Adverse events were primarily gastrointestinal (GI)-related, and a favorable liver safety profile was observed.

BBO-8520 monotherapy in 2L+ NSCLC KRASG12C inhibitor-naïve patients showed:

ORR: 63% (26/41), with a disease control rate (DCR) of 100% (41/41).
Among 28 patients eligible for a six-month follow-up, 75% (21/28) remained on treatment beyond six months.
Tolerable and manageable safety profile with no grade 3 liver enzyme elevations.

"The encouraging efficacy and safety profile with BBO-8520 plus pembrolizumab supports development in patients with KRASG12C-mutant NSCLC who have progressed on a prior G12C inhibitor, a growing population with significant unmet need," said Yong (Ben) Ben, M.D., Chief Medical and Development Officer of BBOT.

Approximately 21,000 patients are expected to be diagnosed with NSCLC harboring KRAS G12C mutations in the United States in 2026. As G12C OFF-state inhibitors potentially move into the first-line setting, BBOT expects a growing population of patients who progress following treatment with a G12C inhibitor and for whom there is currently no approved targeted therapy.

Strategic Prioritization:

BBOT is focusing its capital and resources on opportunities that offer the highest probability of success and greatest potential benefit for patients:

BBO-8520 in combination with pembrolizumab in 2L+, KRASG12C inhibitor-experienced NSCLC patients.
BBO-11818 and BBO-10203 internal combination and independent combinations with standard of care agents in KRAS-mutant cancers.

Financial Position and Upcoming Milestones

As of June 30, 2026, BBOT had approximately $344.1 million in cash, cash equivalents and marketable securities which BBOT projects will fund operations into 2028. BBOT expects the following data catalysts over the next 12 months:

BBO-11818 and BBO-10203 monotherapy data update in the fourth quarter of 2026.
Expanded BBO-8520 plus pembrolizumab dataset in 2L+ KRASG12C inhibitor-experienced NSCLC expected in mid-2027.
Data from BBO-11818 and BBO-10203 internal and standard-of-care combination cohorts in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) expected in mid-2027.

(Press release, BridgeBio Oncology Therapeutics, SEP 8, 2026, View Source [SID1234670660])

On September 8, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it will participate in the H.C. Wainwright 28th Annual Global Investment Conference. The conference is being held on September 14 – 16, 2026 at the Lotte New York Palace Hotel.

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Eric Poma, Ph.D., Chief Executive Officer of Calidi Biotherapeutics will hold one-on-one meetings with investors from September 14 – 16. A virtual presentation will be available on-demand starting Friday, September 11 at 7:00 AM ET. The presentation will be available for registered attendees via the conference platform.

To request a meeting and to register for the conference: View Source

(Press release, Calidi Biotherapeutics, SEP 8, 2026, https://www.globenewswire.com/news-release/2026/09/08/3357560/0/en/calidi-biotherapeutics-to-participate-in-the-h-c-wainwright-28th-annual-global-investment-conference.html [SID1234670659])

On September 8, 2026 InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate clinical trials for ICP-B381, the novel bispecific ADC targeting PSMA and STEAP1, for the treatment of solid tumors including prostate cancer. ICP-B381 is InnoCare’s first bispecific ADC to enter the clinic and the third ADC to enter clinical trials.

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ICP-B381 is InnoCare’s first bispecific ADC built on its proprietary ADC technology platform, comprising a humanized anti- PSMA/STEAP1 antibody conjugated to a potent proprietary payload via a next-generation irreversible linker. By engaging PSMA and STEAP1 simultaneously, ICP-B381 is designed to address heterogeneous tumor cell populations and reduce the risk of tumor escape, potentially benefiting a broader range of patients. In preclinical studies, ICP-B381 demonstrated robust and dose-dependent antitumor activity in a 22Rv1 human prostate cancer xenograft model, outperforming the corresponding single-target PSMA-ADC and STEAP1-ADC at the same dose, with favorable tolerability.

PSMA and STEAP1 are significantly overexpressed in prostate cancer cells with limited expression in normal tissue, making them highly promising therapeutic targets, particularly in metastatic castration-resistant prostate cancer (mCRPC). Currently, no bispecific ADC targeting PSMA and STEAP1 has been approved for marketing globally.

Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, said, "The IND approval of ICP-B381, our first bispecific ADC, is an important milestone for our proprietary ADC platform and reflects the progress we have made in building differentiated ADC candidates. We look forward to advancing ICP-B381 into the clinic and to developing more differentiated ADC candidates to address the needs of patients globally."

Prostate cancer is one of the most common malignancies among men worldwide with an estimated 1.5 million new cases in 2024. It is the most frequently diagnosed cancer in men in nearly two-thirds of the world’s countries.

(Press release, InnoCare Pharma, SEP 8, 2026, View Source [SID1234670658])

On September 8, 2026 BrainChild Bio, Inc., a clinical-stage biotechnology company developing CAR T cell therapies to treat tumors in the central nervous system, reported that the company has closed a $116 million Series A financing. An undisclosed private family fund and foundation, aligned with BrainChild Bio’s mission, led the financing round, with participation from the company’s initial investor, Seattle Children’s, and new investor WRF Capital.

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Proceeds from the Series A financing will be used to support the ILLUMINATE Phase 2 study, a pivotal clinical trial (NCT07680439) to evaluate BCB-276, the company’s investigational B7-H3-targeted autologous CAR T cell therapy, for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and aggressive pediatric brainstem tumor with limited treatment options. In addition, these funds will support the continued development of BCB-214, the company’s triple-targeting CAR T cell therapy being advanced to initial clinical testing in glioblastoma. BrainChild Bio’s pipeline programs leverage the company’s CAR T cell therapy platform to treat tumors of the central nervous system (CNS), based on an exclusive license to technology developed at Seattle Children’s, announced in December 2023.

"Our path to building BrainChild Bio has led us to secure the support of a unique and committed syndicate of investors who share our mission to prioritize therapeutic innovation for children with cancer, while also rapidly advancing new science that can change the course of brain cancers for a wider population," said Steven Brugger, Chief Executive Office of BrainChild Bio. "We believe the time is right to show the breakthrough potential for our CAR T cell therapeutic approach with BCB-276 for DIPG which is a devastating pediatric brain cancer, as well as accelerate our efforts to advance other CAR T cell therapies for pediatric and adult brain tumors."

Since the company’s launch, BrainChild Bio has advanced BCB-276 into a registration-stage clinical development program for DIPG. Building on the foundational clinical experience generated at Seattle Children’s, the company optimized the therapeutic product for late-stage clinical development, established the manufacturing, quality, and regulatory infrastructure required to support a registrational program. These efforts culminated in the initiation of the ILLUMINATE Phase 2 clinical trial, a pivotal registrational study designed to support a future Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for the treatment of DIPG.

"This financing enables us to chart our path forward to serve the children and families afflicted with devastating brain tumors and represents a new paradigm for treating CNS brain tumors in children and adults," stated Michael Jensen, MD, Founder and Chief Scientific Officer of BrainChild Bio. "Our team at BrainChild Bio is steadfast in its commitment to harness CAR T cell technology in CNS tumors and we are uniquely positioned to do so."

About Diffuse Intrinsic Pontine Glioma (DIPG) and Application of CAR T cell Therapies

Diffuse intrinsic pontine glioma (DIPG) is a primary high-grade brain tumor that arises in the pons and is uniformly fatal. DIPG affects approximately 300 children per year in the U.S. with the majority of diagnoses made in children between 5 and 10 years of age. Current standard-of-care treatment remains limited to palliative focal radiation therapy which results in a median overall survival of only about 11 months from diagnosis.1

BrainChild Bio’s autologous CAR T cell therapy offers the potential to overcome barriers to effective therapies for DIPG, including the precarious location of the tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains relatively intact during tumor progression. BrainChild Bio’s CAR T cell therapies are engineered to be administered by locoregional delivery directly into the cerebrospinal fluid, permitting infused CAR T cells to directly access the tumor bed using an in-dwelling reservoir-catheter. This allows for extensive exposure of the pons to cerebrospinal fluid flow from the ventricular system, repetitive infusions of CAR T cells for more durable and sustained efficacy, and local therapeutic administration to minimize on-target, off-tumor toxicities.

(Press release, BrainChild Bio, SEP 8, 2026, View Source [SID1234670657])